Checklist According to ISO IEC 17065:2012 for bodies certifying products, process and services

Transcription

1 Name of Certifying Body Address of Certifying Body Case number Date of assessment With several locations Yes No Assessed locations: (Name)/Address: (Name)/Address: (Name)/Address: Assessed area (technical fields of Certifying Body, certification fields, sector-specific requirements) Details of the assessor Lead assessor System assessor Assessor Technical expert Observer Name Institution Telephone / Fax /

2 General remarks / notes to the use of the checklist for certifying bodies This checklist for Certifying bodies is based on the standard text of ISO IEC 17021:2012. The notes are not requirements. The 1 st column refers to the ISO IEC 17021:2012 clauses and the 2 nd column to the related standard text. In 3 rd column, the applicant shall fill in the following information: Where is the implementation of this requirement documented? (Indication of reference documents) Requirements which do not apply shall be marked as 0 with duly substantiated reasons. In 4 th column, the assessor shall make an evaluation during the preparation of assessment (document review - A doc.) and in 5 th column, assessor shall justify the reasons noncritical nonconformity verified or critical nonconformity verified in column 3. With no non-conformity for a standard item, the evaluation will suffice in line one of the clause. Findings recognized during the preparation and during the assessment shall be filled in the assessment report as a summary. There reference may also be made to the Objective evidence (OE), Reviewed documents (RD) or to other annexes. Where is the implementation of this requirement documented? A doc. A onsite 4 General requirements 4.1 Legal and contractual matters Legal responsibility The certification body (CB) shall be a legal entity, or a defined part of a legal entity, such that the legal entity can be held legally responsible for all its certification activities Certification agreement The CB shall have a legally enforceable agreement for the provision of certification activities to its clients. Certification agreements shall take into account the responsibilities of the CB and its clients The CB shall ensure its certification agreement requires that the client comply at least, with the following:

3 a) the client always fulfils the certification requirements (see 3.7), including implementing appropriate changes when they are communicated by the CB (see 7.10); b) if the certification applies to Ongoing production, the certified product continues to fulfil the product requirements (see 3.8); c) the client makes all necessary arrangements for 1) the conduct of the evaluation (see 3.3) and surveillance (if required), including provision for examining documentation and records, and access to the relevant equipment, location(s), area(s), personnel, and client's subcontractors; 2) investigation of complaints; 3) the participation of observers, if applicable; d) the client makes claims regarding certification consistent with the scope of certification (see 3.10); e) the client does not use its product certification in such a manner as to bring the CB into disrepute and does not make any statement regarding its product certification that the CB may consider misleading or unauthorized; f) upon suspension, withdrawal, or termination of certification, the client discontinues its use of all advertising matter that contains any reference thereto and takes action as required by the certification scheme (e.g. the return of certification documents) and takes any other required measure; g) if the client provides copies of the certification documents to others, the documents shall be reproduced in their entirety or as specified in the certification scheme; h) in making reference to its product certification in communication media such as documents, brochures or advertising, the client complies with the requirements of the CB or as specified by the certification scheme; i) the client complies with any requirements that may be prescribed in the certification scheme relating to the use of marks of conformity, and on information related to the product; NOTE See also ISO/IEC 17030, ISO/IEC Guide 23 and ISO Guide 27. j) the client keeps a record of all complaints made known to it relating to compliance with certification requirements and makes these records available to the CB when requested, and 1) takes appropriate action with respect to such complaints and any deficiencies found in products that affect compliance with the requirements for certification; 2) documents the actions taken; k) the client informs the CB, without delay, of changes that may affect its ability to conform with the certification requirements.

4 4.1.3 Use of license, certificates and marks of conformity The CB shall exercise the control as specified by the certification scheme over ownership, use and display of licenses, certificates, marks of conformity, and any other mechanisms for indicating a product is certified Incorrect references to the certification scheme, or misleading use of licenses, certificates, marks, or any other mechanism for indicating a product is certified, found in documentation or other publicity, shall be dealt with by suitable action. 4.2 Management of Impartiality Certification activities shall be undertaken impartially The CB shall be responsible for the impartiality of its certification activities and shall not allow commercial, financial or other pressures to compromise impartiality The CB shall identify risks to its impartiality on an ongoing basis. This shall include those risks that arise from its activities, from its relationships, or from the relationships of its personnel (see ). However, such relationships may not necessarily present a CB with a risk to impartiality If a risk to impartiality is identified, the CB shall be able to demonstrate how it eliminates or minimizes such risk. This information shall be made available to the mechanism specified in The CB shall have top management commitment to impartiality The CB and any part of the same legal entity and entities under its organizational control (see 7.6.4) shall not: a) be the designer, manufacturer, installer, distributer or maintainer of the certified product; b) be the designer, implementer, operator or maintainer of the certified process; c) be the designer, implementer, provider or maintainer of the certified service; d) offer or provide consultancy (see 3.2) to its clients; e) offer or provide management system consultancy or internal auditing to its clients where the certification scheme requires the evaluation of the client s management system The CB shall ensure that activities of separate legal entities, with which the CB or the legal entity of which it forms a part has relationships, do not compromise the impartiality of its certification activities When the separate legal entity in offers or produces the certified product (including products to be certified) or offers or provides consultancy (see 3.2), the CB's management personnel and personnel in the review and certification decision-making process shall not be involved in the activities of the separate legal entity. The personnel of the separate legal entity shall not be involved in the management of the CB, the review, or the certification decision.

5 4.2.9 The CB's activities shall not be marketed or offered as linked with the activities of an organization that provides consultancy (see 3.2). A CB shall not state or imply that certification would be simpler, easier, faster or less expensive if a specified consultancy organization were used Within a period specified by the CB, personnel shall not be used to review or make a certification decision for a product for which they have provided consultancy (see 3.2) The CB shall take action to respond to any risks to its impartiality, arising from the actions of other persons, bodies or organizations, of which it becomes aware All CB personnel (either internal or external) or committees who could influence the certification activities shall act impartially. 4.3 Liability and financing The CB shall have adequate arrangements (e.g. insurance or reserves) to cover liabilities arising from its operations The CB shall have the financial stability and resources required for its operations. 4.4 Non-discriminatory conditions The policies and procedures under which the CB operates, and the administration of them, shall be non-discriminatory. Procedures shall not be used to impede or inhibit access by applicants, other than as provided for in this International Standard The CB shall make its services accessible to all applicants whose activities fall within the scope of its operations Access to the certification process shall not be conditional upon the size of the client or membership of any association or group, nor shall certification be conditional upon the number of certifications already issued. There shall not be undue financial or other conditions The CB shall confine its requirements, evaluation, review, decision and surveillance (if any) to those matters specifically related to the scope of certification. 4.5 Confidentiality The CB shall be responsible, through legally enforceable commitments, for the management of all information obtained or created during the performance of certification activities. Except for information that the client makes publicly available, or when agreed between the CB and the client (e.g. for the purpose of responding to complaints), all other information is considered proprietary information and shall be regarded as confidential. The CB shall inform the client, in advance, of the information it intends to place in the public domain When the CB is required by law or authorized by contractual arrangements to release confidential information, the client or person concerned shall, unless prohibited by law, be notified of the information provided Information about the client obtained from sources other than the client (e.g. from the complainant or from regulators) shall be treated as confidential.

6 4.6 Publicly available information The CB shall maintain (through publications, electronic media or other means), and make available upon request, the following: a) information about (or reference to) the certification scheme(s), including evaluation procedures, rules and procedures for granting, for maintaining, for extending or reducing the scope of, for suspending, for withdrawing or for refusing certification; b) a description of the means by which the CB obtains financial support and general information on the fees charged to applicants and to clients; c) a description of the rights and duties of applicants and clients, including requirements, restrictions or limitations on the use of the CB's name and certification mark and on the ways of referring to the certification granted; d) information about procedures for handling complaints and appeals. 5 Structural requirements 5.1 Organizational structure and top management Certification activities shall be structured and managed so as to safeguard impartiality The CB shall document its organizational structure, showing duties, responsibilities and authorities of management and other certification personnel and any committees. When the CB is a defined part of a legal entity, the structure shall include the line of authority and the relationship to other parts within the same legal entity The management of the CB shall identify the board, group of persons, or person having overall authority and responsibility for each of the following: a) development of policies relating to the operation of the CB; b) supervision of the implementation of the policies and procedures; c) supervision of the finances of the CB; d) development of certification activities; e) development of certification requirements; f) evaluation (see 7.4); g) review (see 7.5); h) decisions on certification (see 7.6); i) delegation of authority to committees or personnel, as required, to undertake defined activities on its behalf; j) contractual arrangements; k) provision of adequate resources for certification activities; l) responsiveness to complaints and appeals; m) personnel competence requirements; n) management system of the CB (see Clause 8).

7 5.1.4 The CB shall have formal rules for the appointment, terms of reference and operation of any committees that are involved in the certification process (see Clause 7). Such committees shall be free from any commercial, financial and other pressures that might influence decisions. The CB shall retain authority to appoint and withdraw members of such committees. 5.2 Mechanism for safeguarding impartiality The CB shall have a mechanism for safeguarding its impartiality. The mechanism shall provide input on the following: a) the policies and principles relating to the impartiality of its certification activities; b) any tendency on the part of a CB to allow commercial or other considerations to prevent the consistent impartial provision of certification activities; c) matters affecting impartiality and confidence in certification, including openness The mechanism shall be formally documented to ensure the following: a) a balanced representation of significantly interested parties, such that no single interest predominates (internal or external personnel of the CB are considered to be a single interest, and shall not predominate); b) access to all the information necessary to enable it to fulfil all its functions If the top management of the CB does not follow the input of this mechanism, the mechanism shall have the right to take independent action (e.g. informing authorities, accreditation bodies, stakeholders). In taking appropriate action, the confidentiality requirements of 4.5 relating to the client and CB shall be respected. Input that is in conflict with the operating procedures of the CB or other mandatory requirements should not be followed. Management should document the reasoning behind the decision to not follow the input and maintain the document for review by appropriate personnel Although every interest cannot be represented in the mechanism, a CB shall identify and invite significantly interested parties. 6 Resource requirements 6.1 Certification body personnel General The CB shall employ, or have access to, a sufficient number of personnel to cover its operations related to the certification schemes and to the applicable standards and other normative documents The personnel shall be competent for the functions they perform, including making required technical judgments, defining policies and implementing them Personnel, including any committee members, personnel of external bodies, or personnel acting on the CB's behalf, shall keep confidential all information obtained or created during the performance of the certification activities, except as required by law or by the certification scheme.

8 6.1.2 Management of competence for personnel involved in the certification process The CB shall establish, implement and maintain a procedure for management of competencies of personnel involved in the certification process (see Clause 7). The procedure shall require the CB to: a) determine the criteria for the competence of personnel for each function in the certification process, taking into account the requirements of the schemes; b) identify training needs and provide, as necessary, training programmes on certification processes, requirements, methodologies, activities and other relevant certification scheme requirements; c) demonstrate that the personnel have the required competencies for the duties and responsibilities they undertake; d) formally authorize personnel for functions in the certification process; e) monitor the performance of the personnel The CB shall maintain the following records on the personnel involved in the certification process (see Clause 7): a) name and address; b) employer(s) and position held; c) educational qualification and professional status; d) experience and training; e) the assessment of competence; f) performance monitoring; g) authorizations held within the CB; h) date of most recent updating of each record Contract with the personnel The CB shall require personnel involved in the certification process to sign a contract or other document by which they commit themselves to the following: a) to comply with the rules defined by the CB, including those relating to confidentiality (see 4.5) and independence from commercial and other interests; b) to declare any prior and/or present association on their own part, or on the part of their employer, with: 1) a supplier or designer of products, or 2) a provider or developer of services, or 3) an operator or developer of processes to the evaluation or certification of which they are to be assigned; c) to reveal any situation known to them that may present them or the CB with a conflict of interest (see 4.2). Certification bodies shall use this information as input into identifying risks to impartiality raised by the activities of such personnel, or by the organizations that employ them (see 4.2.3).

9 6.2 Resources for evaluation Internal resources When a CB performs evaluation activities, either with its internal resources or with other resources under its direct control, it shall meet the applicable requirements of the relevant International Standards and, as specified by the certification scheme, of other documents. For testing, it shall meet the applicable requirements of ISO/IEC 17025; for inspection, it shall meet the applicable requirements of ISO/IEC 17020; and for management system auditing, it shall meet the applicable requirements of ISO/IEC The impartiality requirements of the evaluation personnel stipulated in the relevant standard shall always be applicable External resources (outsourcing) The CB shall outsource evaluation activities only to bodies that meet the applicable requirements of the relevant International Standards and, as specified by the certification scheme, of other documents. For testing, it shall meet the applicable requirements of ISO/IEC 17025; for inspection, it shall meet the applicable requirements of ISO/IEC 17020; and for management system auditing, it shall meet the applicable requirements of ISO/IEC The impartiality requirements of the evaluation personnel stipulated in the relevant standard shall always be applicable Where evaluation activities are outsourced to non-independent bodies (e.g. client laboratories), the CB shall ensure that the evaluation activities are managed in a manner which provides confidence in the results, and that records are available to justify the confidence The CB shall have a legally binding contract with the body that provides the outsourced service, including provisions for confidentiality and conflict of interest as specified in 6.1.3, item c) The CB shall: a) take responsibility for all activities outsourced to another body; b) ensure that the body that provides outsourced services, and the personnel that it uses, are not involved, either directly or through any other employer, in such a way that the credibility of the results could be compromised; c) have documented policies, procedures and records for the qualification, assessing and monitoring of all bodies that provide outsourced services used for certification activities; d) maintain a list of approved providers of outsourced services; e) implement corrective actions for any breaches of the contract in or other requirements in of which it becomes aware; f) inform the client in advance of outsourcing activities, in order to provide the client with an opportunity to object.

10 7 Process requirements 7.1 General The CB shall operate one or more certification scheme(s) covering its certification activities The requirements against which the products of a client are evaluated shall be those contained in specified standards and other normative documents If explanations are required as to the application of these documents (see 7.1.2) for a specific certification scheme, they shall be formulated by relevant and impartial persons or committees, possessing the necessary technical competence, and shall be made available by the CB upon request. 7.2 Application For application, the CB shall obtain all the necessary information to complete the certification process in accordance with the relevant certification scheme. involve similar products, different locations, etc. 7.3 Application review The CB shall conduct a review of the information obtained (see 7.2) to ensure that: a) the information about the client and the product is sufficient for the conduct of the certification process; b) any known difference in understanding between the CB and the client is resolved, including agreement regarding standards or other normative documents; c) the scope of certification (see 3.10) sought is defined; d) the means are available to perform all evaluation activities; e) the CB has the competence and capability to perform the certification activity The CB shall have a process to identify when the client's request for certification includes a type of product, or a normative document, or a certification scheme with which the CB has no prior experience In these cases (see 7.3.2), the CB shall ensure it has the competence and capability for all the certification activities it is required to undertake, and it shall maintain a record of the justification for the decision to undertake certification The CB shall decline to undertake a specific certification if it lacks any competence or capability for the certification activities it is required to undertake If the CB relies on certifications it has already granted to the client, or has already granted to other clients, to omit any activities, then the CB shall reference the existing certification(s) in its records. If requested by the client, the CB shall provide justification for omission of activities.

11 7.4 Evaluation The CB shall have a plan for the evaluation activities to allow for the necessary arrangements to be managed The CB shall assign personnel to perform each evaluation task that it undertakes with its internal resources (see 6.2.1) The CB shall ensure all necessary information and/or documentation is made available for performing the evaluation tasks The CB shall carry out the evaluation activities that it undertakes with its internal resources (see 6.2.1) and shall manage outsourced resources (see 6.2.2) in accordance with the evaluation plan (see 7.4.1). The products shall be evaluated against the requirements covered by the scope of certification and other requirements specified in the certification scheme The CB shall only rely on evaluation results related to certification completed prior to the application for certification, where it takes responsibility for the results and satisfies itself that the body that performed the evaluation fulfils the requirements contained in and those specified by the certification scheme The CB shall inform the client of all nonconformities If one or more nonconformities have arisen, and if the client expresses interest in continuing the certification process, the CB shall provide information regarding the additional evaluation tasks needed to verify that nonconformities have been corrected If the client agrees to completion of the additional evaluation tasks, the process specified in 7.4 shall be repeated to complete the additional evaluation tasks The results of all evaluation activities shall be documented prior to review (see 7.5). 7.5 Review The CB shall assign at least one person to review all information and results related to the evaluation. The review shall be carried out by person(s) who have not been involved in the evaluation process Recommendations for a certification decision based on the review shall be documented, unless the review and the certification decision are completed concurrently by the same person. 7.6 Certification decision The CB shall be responsible for, and shall retain authority for, its decisions relating to certification The CB shall assign at least one person to make the certification decision based on all information related to the evaluation, its review, and any other relevant information. The certification decision shall be carried out by a person or group of persons [e.g. a committee (see 5.1.4)] that has not been involved in the process for evaluation (see 7.4) The person(s) [excluding members of committees (see 5.1.4)] assigned by the CB to make a certification decision shall be employed by, or shall be under contract with, one of the following: the CB (see 6.1); an entity under the organizational control of the CB (see 7.6.4).

12 7.6.4 A CB s organizational control shall be one of the following: whole or majority ownership of another entity by the CB; majority participation by CB on the board of directors of other entity; a documented authority by the CB over another entity in a network of legal entities (in which the CB resides), linked by ownership or board of director control The persons employed by, or under contract with, entities under organizational control shall fulfil the same requirements of this International Standard as persons employed by, or under contract with, the CB The CB shall notify the client of a decision not to grant certification, and shall identify the reasons for the decision. 7.7 Certification documentation The CB shall provide the client with formal certification documentation that clearly conveys, or permits identification of the following: a) the name and address of the CB; b) the date certification is granted (the date shall not precede the date on which the certification decision was completed); c) the name and address of the client; d) the scope of certification (see 3.10); NOTE Where the standard(s) or other normative document(s) (see 7.1.2) to which conformity is being certified include reference to other standards or normative documents, these do not need to be included in the formal certification documentation. e) the term or expiry date of certification, if certification expires after an established period; f) any other information required by the certification scheme The formal certification documentation shall include the signature or other defined authorization of the person(s) of the CB assigned such responsibility Formal certification documentation (see 7.7) shall only be issued after, or concurrent with, the following: a) the decision to grant or extend the scope of certification (see 7.6.1) has been made; b) certification requirements have been fulfilled; c) the certification agreement (see 4.1.2) has been completed/signed. 7.8 Directory of certified products The CB shall maintain information on certified products which contains at least the following: a) identification of the product; b) the standard(s) and other normative document(s) to which conformity has been certified; c) identification of the client. The parts of this information that need to be published or made available upon request in a directory (through publications, electronic media or other means) are stipulated by the relevant scheme(s). As a minimum, the CB shall provide information, upon request, about the validity of a given certification.

13 7.9 Surveillance If surveillance is required by the certification scheme, or as specified in or 7.9.4, the CB shall initiate surveillance of the product(s) covered by the certification decision in accordance with the certification scheme When surveillance utilizes evaluation, review or a certification decision, the requirements in 7.4, 7.5 or 7.6, respectively, shall be fulfilled When continuing use of a certification mark is authorized for placement on a product (or its packaging, or information accompanying it) (for process or service, see 7.9.4) of a type which has been certified, surveillance shall be established and shall include periodic surveillance of marked products to ensure ongoing validity of the demonstration of fulfillment of product requirements When continuing use of a certification mark is authorized for a process or service, surveillance shall be established and shall include periodic surveillance activities to ensure ongoing validity of the demonstration of fulfillment of process or service requirements Changes affecting certification When the certification scheme introduces new or revised requirements that affect the client, the CB shall ensure these changes are communicated to all clients. The CB shall verify the implementation of the changes by its clients and shall take actions required by the scheme The CB shall consider other changes affecting certification, including changes initiated by the client, and shall decide upon the appropriate action The actions to implement changes affecting certification shall include, if required, the following: evaluation (see 7.4); review (see 7.5); decision (see 7.6); issuance of revised formal certification documentation (see 7.7) to extend or reduce the scope of certification; issuance of certification documentation of revised surveillance activities (if surveillance is part of the certification scheme). These actions shall be completed in accordance with applicable parts of 7.4, 7.5, 7.6, 7.7 and 7.8. Records (see 7.12) shall include the rationale for excluding any of the above activities (e.g. when a certification requirement that is not a product requirement changes, and no evaluation, review or decision activities are necessary) Termination, reduction, suspension or withdrawal of certification When a nonconformity with certification requirements is substantiated, either as a result of surveillance or otherwise, the CB shall consider and decide upon the appropriate action. NOTE Appropriate action can include the following: a) continuation of certification under conditions specified by the CB (e.g. increased surveillance); b) reduction in the scope of certification to remove nonconforming product variants; c) suspension of the certification pending remedial action by the client; d) withdrawal of the certification.

14 When the appropriate action includes evaluation, review or a certification decision, the requirements in 7.4, 7.5 or 7.6, respectively, shall be fulfilled If certification is terminated (by request of the client), suspended or withdrawn, the CB shall take actions specified by the certification scheme and shall make all necessary modifications to formal certification documents, public information, authorizations for use of marks, etc., in order to ensure it provides no indication that the product continues to be certified. If a scope of certification is reduced, the CB shall take actions specified by the certification scheme and shall make all necessary modifications to formal certification documents, public information, authorizations for use of marks, etc., in order to ensure the reduced scope of certification is clearly communicated to the client and clearly specified in certification documentation and public information If certification is suspended, the CB shall assign one or more persons to formulate and communicate the following to the client: actions needed to end suspension and restore certification for the product(s) in accordance with the certification scheme; any other actions required by the certification scheme. These persons shall be competent in their knowledge and understanding of all aspects of the handling of suspended certifications (see 6.1) Any evaluations, reviews or decisions needed to resolve the suspension, or that are required by the certification scheme, shall be completed in accordance with the applicable parts of 7.4, 7.5, 7.6, 7.7.3, 7.9 and If certification is reinstated after suspension, the CB shall make all necessary modifications to formal certification documents, public information, authorizations for use of marks, etc., in order to ensure all appropriate indications exist that the product continues to be certified. If a decision to reduce the scope of certification is made as a condition of reinstatement, the CB shall make all necessary modifications to formal certification documents, public information, authorizations for use of marks, etc., in order to ensure the reduced scope of certification is clearly communicated to the client and clearly specified in certification documentation and public information Records The CB shall retain records to demonstrate that all certification process requirements (those in this International Standard and those of the certification scheme) have been effectively fulfilled (see also 8.4) The CB shall keep records confidential. Records shall be transported, transmitted and transferred in a way that ensures confidentiality is maintained (see also 4.5) If the certification scheme involves complete re-evaluation of the product(s) within a determined cycle, records shall be retained at least for the current and the previous cycle. Otherwise, records shall be retained for a period defined by the CB. NOTE In defining retention times, legal circumstances and recognition arrangements can be considered.

15 7.13 Complaints and appeals The CB shall have a documented process to receive, evaluate and make decisions on complaints and appeals. The CB shall record and track complaints and appeals, as well as actions undertaken to resolve them Upon receipt of a complaint or appeal, the CB shall confirm whether the complaint or appeal relates to certification activities for which it is responsible and, if so, shall address it The CB shall acknowledge receipt of a formal complaint or appeal The CB shall be responsible for gathering and verifying all necessary information (as far as possible) to progress the complaint or appeal to a decision The decision resolving the complaint or appeal shall be made by, or reviewed and approved by, person(s) not involved in the certification activities related to the complaint or appeal To ensure that there is no conflict of interest, personnel (including those acting in a managerial capacity) who have provided consultancy (see 3.2) for a client, or been employed by a client, shall not be used by the CB to review or approve the resolution of a complaint or appeal for that client within two years following the end of the consultancy or employment Whenever possible, the CB shall give formal notice of the outcome and the end of the complaint process to the complainant The CB shall give formal notice of the outcome and the end of the appeal process to the appellant The CB shall take any subsequent action needed to resolve the complaint or appeal. 8 Management system requirements 8.1 Options General The CB shall establish and maintain a management system that is capable of achieving the consistent fulfillment of the requirements of this International Standard in accordance with either Option A or Option B Option A The management system of the CB shall address the following: general management system documentation (e.g. manual, policies, definition of responsibilities, see 8.2); control of documents (see 8.3); control of records (see 8.4); management review (see 8.5); internal audit (see 8.6); corrective actions (see 8.7); preventive actions (see 8.8) Option B A CB that has established and maintains a management system, in accordance with the requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent fulfillment of the requirements of this International Standard, fulfils the management system clause requirements (see 8.2 to 8.8).

16 8.2 General management system documentation (Option A) The CB's top management shall establish, document, and maintain policies and objectives for fulfillment of this International Standard and the certification scheme and shall ensure the policies and objectives are acknowledged and implemented at all levels of the CB s organization The CB's top management shall provide evidence of its commitment to the development and implementation of the management system and its effectiveness in achieving consistent fulfillment of this International Standard The CB's top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that include the following: a) ensuring that processes and procedures needed for the management system are established, implemented and maintained; b) reporting to top management on the performance of the management system and any need for improvement All documentation, processes, systems, records, etc. related to the fulfillment of the requirements of this International Standard shall be included, referenced, or linked to documentation of the management system All personnel involved in certification activities shall have access to the parts of the management system documentation and related information that are applicable to their responsibilities. 8.3 Control of documents (Option A) The CB shall establish procedures to control the documents (internal and external) that relate to the fulfillment of this International Standard The procedures shall define the controls needed to: a) approve documents for adequacy prior to issue; b) review and update (as necessary) and re-approve documents; c) ensure that changes and the current revision status of documents are identified; d) ensure that relevant versions of applicable documents are available at points of use; e) ensure that documents remain legible and readily identifiable; f) ensure that documents of external origin are identified and their distribution controlled; g) prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 8.4 Control of records (Option A) The CB shall establish procedures to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of its records related to the fulfillment of this International Standard The CB shall establish procedures for retaining records (see 7.12) for a period consistent with its contractual and legal obligations. Access to these records shall be consistent with the confidentiality arrangements.

17 8.5 Management review (Option A) General The CB's top management shall establish procedures to review its management system at planned intervals, in order to ensure its continuing suitability, adequacy and effectiveness, including the stated policies and objectives related to the fulfilment of this International Standard These reviews shall be conducted at least once a year. Alternatively, a complete review broken up into segments shall be completed within a 12-month time frame. Records of reviews shall be maintained Review inputs The input to the management review shall include information related to the following: a) results of internal and external audits; b) feedback from clients and interested parties related to the fulfillment of this International Standard; c) feedback from the mechanism for safeguarding impartiality; d) the status of preventive and corrective actions; e) follow-up actions from previous management reviews; f) the fulfillment of objectives; g) changes that could affect the management system; h) appeals and complaints Review outputs The outputs from the management review shall include decisions and actions related to the following: a) improvement of the effectiveness of the management system and its processes; b) improvement of the CB related to the fulfilment of this International Standard; c) resource needs. 8.6 Internal audits (Option A) The CB shall establish procedures for internal audits to verify that it fulfils the requirements of this International Standard and that the management system is effectively implemented and maintained An audit programme shall be planned, taking into consideration the importance of the processes and areas to be audited, as well as the results of previous audits Internal audits shall normally be performed at least once every 12 months, or completed within a 12-month time frame for segmented (or rolling) internal audits. A documented decision-making process shall be followed to change (reduce or restore) the frequency of internal audits or the time frame in which internal audits shall be completed. Such changes shall be based on the relative stability and ongoing effectiveness of the management system. Records of decisions to change the frequency of internal audits, or the time frame in which they will be completed, including the rationale for the change, shall be maintained The CB shall ensure that: a) internal audits are conducted by personnel knowledgeable in certification, auditing and the requirements of this International Standard; b) auditors do not audit their own work; c) personnel responsible for area audited are informed of the outcome any actions resulting from internal audits are taken in a timely and appropriate manner; d) any opportunities for improvement are identified.

18 8.7 Corrective actions (Option A) The CB shall establish procedures for identification and management of nonconformities in its operations The CB shall also, where necessary, take actions to eliminate the causes of nonconformities in order to prevent recurrence Corrective actions shall be appropriate to the impact of the problems encountered The procedures for corrective actions shall define requirements for the following: a) identifying nonconformities (e.g. from complaints and internal audits); b) determining the causes of nonconformity; c) correcting nonconformities; d) evaluating the need for actions to ensure that nonconformities do not recur; e) determining and implementing the actions needed in a timely manner; f) recording the results of actions taken; g) reviewing the effectiveness of corrective actions 8.8 Preventive actions (Option A) The CB shall establish procedures for taking preventive actions to eliminate the causes of potential nonconformities Preventive actions taken shall be appropriate to the probable impact of the potential problems The procedures for preventive actions shall define requirements for the following: a) identifying potential nonconformities and their causes; b) evaluating the need for action to prevent the occurrence of nonconformities; c) determining and implementing the action needed; d) recording the results of actions taken; e) reviewing the effectiveness of the preventive actions taken. Assessor: Date / signature Note: The signature of the assessor does not confirm the complete correctness of the reference documents provided by the CAB.